Skip to main content

Advertisement

SpringerLink
Log in

A Multicenter Predictive Score for Amputation-Free Survival for Patients Operated on with an Heparin-Bonded ePTFE Graft for Critical Limb Ischemia

  • Original Scientific Report
  • Published:
World Journal of Surgery Aims and scope Submit manuscript

Abstract

Aim of the study

To retrospectively create a predictive score for estimating amputation-free survival (AFS) in patients with critical limb ischemia (CLI) operated on with the use of a heparin-bonded expanded polytetrafluoroethylene (ePTFE) bypass graft (Hb-ePTFE).

Methods

Over a 13-year period, ending in March 2015, a Hb-ePTFE graft was implanted in 683 patients undergoing below-knee revascularization for CLI in seven Italian vascular hospitals. Data concerning these interventions were retrospectively collected in a multicenter registry with a dedicated database. Univariate and multivariable analyses with Kaplan–Meier estimates were used to identify potential significant predictors of AFS at 5 years, and then a predictive risk score was constructed. A qualitative assessment of the Kaplan–Meier survival estimates for each integer score was performed, and subgroups of risk were stratified on the basis of the primary end point.

Results

Overall, estimated 5-year AFS rate was 48.3 % (SE 0.024). At multivariate analysis, older age, coronary artery disease, end-stage renal disease, tissue loss and poor runoff score were predictors of AFS. The integer score ranged from 0 to 11; Kaplan–Meier analysis for AFS in each score group identified three subgroups with significant differences at 5 years: low-risk subgroup (scores from 0 to 2, 67.7 %), medium-risk subgroup (scores 3 and 4, 49.2 %, p < 0.001 in comparison with low-risk subgroup) and high-risk subgroup (scores from 5 to 11, 25.2 %, p < 0.001 in comparison with either low-risk subgroup or medium-risk subgroup).

Conclusions

A category of low-risk patients with CLI treated with the indexed graft does exist, thus suggesting a primary role for Hb-ePTFE in such patients. A prospective validation of such a score is necessary.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1

Similar content being viewed by others

References

  1. Sachs T, Pomposelli F, Hamdan A, Wyers M, Schermerhorn M (2011) Trends in the national outcomes and costs for claudication and limb threatening ischemia: angioplasty vs bypass graft. J Vasc Surg 54(4):1021–1031

    Article  PubMed  Google Scholar 

  2. Goodney PP, Beck AW, Nagle J, Welch HG, Zwolak RM (2009) National trends in lower extremity bypass surgery, endovascular interventions, and major amputations. J Vasc Surg 50(1):54–60

    Article  PubMed  Google Scholar 

  3. Conte MS (2013) Critical appraisal of surgical revascularization for critical limb ischemia. J Vasc Surg 57(2 Suppl):8S–13S

    Article  PubMed  Google Scholar 

  4. Taylor SM, Cull DL, Kalbaugh CA, Cass AL, Harmon SA, Langan EM 3rd et al (2007) Critical analysis of clinical success after surgical bypass for lower-extremity ischemic tissue loss using a standardized definition combining multiple parameters: a new paradigm of outcomes assessment. J Am Coll Surg 204(5):831–838

    Article  PubMed  Google Scholar 

  5. Dosluoglu HH, Wang J, Defranks-Anain L, Rainstein M, Nader ND (2008) A simple subclassification of American Society of Anesthesiology III patients undergoing peripheral revascularization based on functional capacity. J Vasc Surg 47(4):766–772

    Article  PubMed  Google Scholar 

  6. Bertges DJ, Goodney PP, Zhao Y, Schanzer A, Nolan BW, Likosky DS et al (2010) The Vascular Study Group of New England Cardiac Risk Index (VSG-CRI) predicts cardiac complications more accurately than the Revised Cardiac Risk Index in vascular surgery patients. J Vasc Surg 52(3):674–683

    Article  PubMed  Google Scholar 

  7. Crawford RS, Cambria RP, Abularrage CJ, Conrad MF, Lancaster RT, Watkins MT et al (2010) Preoperative functional status predicts perioperative outcomes after infrainguinal bypass surgery. J Vasc Surg 51(2):351–358

    Article  PubMed  Google Scholar 

  8. Goodney PP, Schanzer A, Demartino RR, Nolan BW, Hevelone ND, Conte MS et al (2011) Validation of the Society for Vascular Surgery’s objective performance goals for critical limb ischemia in everyday vascular surgery practice. J Vasc Surg 54(1):100–108

    Article  PubMed  PubMed Central  Google Scholar 

  9. Bargellini I, Piaggesi A, Cicorelli A, Rizzo L, Cervelli R, Iacopi E et al (2013) Predictive value of angiographic scores for the integrated management of the ischemic diabetic foot. J Vasc Surg 57(5):1204–1212

    Article  PubMed  Google Scholar 

  10. Schanzer A (2009) Impact of comorbidities on decision-making in chronic critical limb ischemia. Semin Vasc Surg 22(4):209–215

    Article  PubMed  Google Scholar 

  11. Dorigo W, Pulli R, Castelli P, Dorrucci V, Ferilli F, De Blasis G et al (2011) A multicenter comparison between autologous saphenous vein and heparin-bonded expanded polytetrafluoroethylene (ePTFE) graft in the treatment of critical limb ischemia in diabetics. J Vasc Surg 54(5):1332–1338

    Article  PubMed  Google Scholar 

  12. Dorigo W, Pulli R, Piffaretti G, Castelli P, Griselli F, Dorrucci V et al (2012) Results from an Italian multicentric registry comparing heparin-bonded ePTFE graft and autologous saphenous vein in below-knee femoro-popliteal bypasses. J Cardiovasc Surg 53(2):187–194

    CAS  Google Scholar 

  13. Schanzer A, Mega J, Meadows J, Samson RH, Bandyk DF, Conte MS (2008) Risk stratification in critical limb ischemia: derivation and validation of a model to predict amputation-free survival using multicenter surgical outcomes data. J Vasc Surg 48(6):1464–1471

    Article  PubMed  PubMed Central  Google Scholar 

  14. Rutherford RB, Baker JD, Ernst C, Johnston KW, Porter JM, Ahn S et al (1997) Recommended standards for reports dealing with lower extremity ischemia: revised version. J Vasc Surg 26(3):517–538

    Article  CAS  PubMed  Google Scholar 

  15. Shah DM, Darling RC 3rd, Chang BB, Fitzgerald KM, Paty PS, Leather RP (1995) Long-term results of in situ saphenous vein bypass. Analysis of 2058 cases. Ann Surg 222(4):438–446

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  16. Sayers RD, Raptis S, Berce M, Miller JH (1998) Long-term results of femorotibial bypass with vein or polytetrafluoroethylene. Br J Surg 85(7):934–938

    Article  CAS  PubMed  Google Scholar 

  17. Jackson MR, Belott TP, Dickason T, Kaiser WJ, Modrall JG, Valentine RJ et al (2000) The consequences of a failed femoropopliteal bypass grafting: comparison of saphenous vein and PTFE grafts. J Vasc Surg 32(3):498–504

    Article  CAS  PubMed  Google Scholar 

  18. Pomposelli FB, Kansal N, Hamdan AD, Belfield A, Sheahan M, Campbell DR et al (2003) A decade of experience with dorsalis pedis artery bypass: analysis of outcome in more than 1000 cases. J Vasc Surg 37(2):307–315

    Article  PubMed  Google Scholar 

  19. Neville RF, Lidsky M, Capone A, Babrowicz J, Rahbar R, Sidawy AN (2012) An expanded series of distal bypass using the distal vein patch technique to improve prosthetic graft performance in critical limb ischemia. Eur J Vasc Endovasc Surg 44(2):177–182

    Article  CAS  PubMed  Google Scholar 

  20. Lees T, Troëng T, Thomson IA, Menyhei G, Simo G, Beiles B et al (2012) International variations in infrainguinal bypass surgery—a VASCUNET report. Eur J Vasc Endovasc Surg 44(2):185–192

    Article  CAS  PubMed  Google Scholar 

  21. Conte MS, Belkin M, Upchurch GR, Mannick JA, Whittemore AD, Donaldson MC (2001) Impact of increasing comorbidity on infrainguinal reconstruction: a 20-year perspective. Ann Surg 233(3):445–452

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  22. Meltzer AJ, Graham A, Connolly PH, Meltzer EC, Karwowski JK, Bush HL et al (2013) The Comprehensive Risk Assessment for Bypass (CRAB) facilitates efficient perioperative risk assessment for patients with critical limb ischemia. J Vasc Surg 57(5):1186–1195

    Article  PubMed  Google Scholar 

  23. Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG et al (2007) Inter-society consensus for the management of peripheral arterial disease (TASC II). Eur J Vasc Endovasc Surg 33(Suppl 1):S1–S75

    Article  PubMed  Google Scholar 

  24. Abu Dabrh AM, Steffen MW, Undavalli C, Asi N, Wang Z, Elamin MB et al (2015) The natural history of untreated severe or critical limb ischemia. J Vasc Surg 62(6):1642–1651

    Article  PubMed  Google Scholar 

  25. Pulli R, Dorigo W, Castelli P, Dorrucci V, Ferilli F, De Blasis G et al (2010) Midterm results from a multicenter registry on the treatment of infrainguinal critical limb ischemia using a heparin-bonded ePTFE graft. J Vasc Surg 51(5):1167–1177

    Article  PubMed  Google Scholar 

  26. Baldwin ZK, Pearce BJ, Curi MA, Desai TR, McKinsey JF, Bassiouny HS et al (2004) Limb salvage after infrainguinal bypass graft failure. J Vasc Surg 39(5):951–957

    Article  PubMed  Google Scholar 

  27. Mills JL Sr, Conte MS, Armstrong DG, Pomposelli FB, Schanzer A, Sidawy AN et al (2014) The Society for Vascular Surgery Lower Extremity Threatened Limb Classification System: risk stratification based on wound, ischemia, and foot infection (WIfI). J Vasc Surg 59(1):220–234

    Article  PubMed  Google Scholar 

  28. Akbari CM, Pomposelli FB Jr, Gibbons GW, Campbell DR, Pulling MC, Mydlarz D et al (2000) Lower extremity revascularization in diabetes: late observations. Arch Surg 135(4):452–456

    Article  CAS  PubMed  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Vascular Surgery, Department of Cardiothoracic and Vascular Surgery, Careggi University Teaching Hospital, University of Florence School of Medicine, Largo Brambilla, 3, 50134, Florence, Italy

    Walter Dorigo & Carlo Pratesi

  2. Vascular Surgery, Department of Surgery and Morphological Sciences, Circolo University Teaching Hospital, University of Insubria School of Medicine, Varese, Italy

    Gabriele Piffaretti & Patrizio Castelli

  3. Vascular Surgery, Department of Cardiothoracic Surgery, University of Bari, Bari, Italy

    Raffaele Pulli

Authors
  1. Walter Dorigo
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Gabriele Piffaretti
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Raffaele Pulli
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Patrizio Castelli
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Carlo Pratesi
    View author publications

    You can also search for this author in PubMed Google Scholar

Consortia

PROPATEN Italian Registry Group

  • Carlo Pratesi
  • , Walter Dorigo
  • , Raffaele Pulli
  • , Alessandro Alessi Innocenti
  • , Giovanni Pratesi
  • , Giovanni De Blasis
  • , Luciano Scalisi
  • , Vincenzo Monaca
  • , Giuseppe Battaglia
  • , Vittorio Dorrucci
  • , Enrico Vecchiati
  • , Giovanni Casali
  • , Fiore Ferilli
  • , Paolo Ottavi
  • , Patrizio Castelli
  • , Gabriele Piffaretti
  •  & Marco Franchin

Corresponding author

Correspondence to Walter Dorigo.

Ethics declarations

Conflict of interest

None.

PROPATEN Italian Registry Group

Coordinating Center: Firenze: Carlo Pratesi, Walter Dorigo, Raffaele Pulli, Alessandro Alessi Innocenti, Giovanni Pratesi; Vascular Surgery, Department of Cardiothoracic and Vascular Surgery, Careggi University Teaching Hospital, University of Florence School of Medicine, Florence. Participating Centers: Avezzano: Giovanni De Blasis, Luciano Scalisi; Vascular and Endovascular Surgery, “SS. Filippo e Nicola” Hospital. Catania: Vincenzo Monaca, Giuseppe Battaglia; Vascular Surgery, “Vittorio Emanuele” Ferrarotto Hospital. Mestre: Vittorio Dorrucci; Vascular Surgery, “Umberto I” Hospital. Reggio Emilio: Enrico Vecchiati, Giovanni Casali; Vascular Surgery, “S. Maria Nuova” Hospital. Terni: Fiore Ferilli, Paolo Ottavi; Vascular Surgery, “S. Maria” Hospital. Varese: Patrizio Castelli, Gabriele Piffaretti, Marco Franchin; Vascular Surgery, Department of Surgery and Morphological Sciences, Circolo University Teaching Hospital, University of Insubria School of Medicine, Varese, Italy.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Dorigo, W., Piffaretti, G., Pulli, R. et al. A Multicenter Predictive Score for Amputation-Free Survival for Patients Operated on with an Heparin-Bonded ePTFE Graft for Critical Limb Ischemia. World J Surg 41, 306–313 (2017). https://doi.org/10.1007/s00268-016-3674-z

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00268-016-3674-z

Keywords

Search

Navigation